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Article ; Online: The patient experience of relapsed refractory multiple myeloma and perspectives on emerging therapies.

Crawford, Rebecca / Gries, Katharine S / Valluri, Satish / Fastenau, John / Morrison, Ross / Yeh, Tzu-Min / Olyslager, Yunsi / Goldberg, Jenna D / Schecter, Jordan M / Jackson, Carolyn C / Deraedt, William / Doward, Lynda

Cancer reports (Hoboken, N.J.)

2022 Volume 5, Issue 11, Page(s) e1603

Abstract: Background: Relapsed refractory multiple myeloma (RRMM) is a disease that is nonresponsive or progressive on therapy, and although patients can achieve remission, relapse is common. As more treatment options become available for multiple myeloma (MM), ... ...

Abstract	Background: Relapsed refractory multiple myeloma (RRMM) is a disease that is nonresponsive or progressive on therapy, and although patients can achieve remission, relapse is common. As more treatment options become available for multiple myeloma (MM), it is important to understand patients' experiences of current and emerging therapies. Aims: This study aimed to better understand patient experiences with treatment and therapies for MM using qualitative interviews and patient-reported information (PRI) shared on social media. Methods: Semistructured qualitative interviews were conducted with adults with RRMM who resided in the United States. In addition to the interviews, PRI was collected from YouTube and a patient advocacy website. Key themes from the interviews and PRI were summarized, and illustrative quotes were extracted. Results: Twenty participants were interviewed; 11 were female, and mean (standard deviation) age was 60 (7.0) years. The PRI included 14 posts and 19 unique contributors (10 were female). Similar treatment-related symptoms were reported in the interviews and PRI. Fatigue and pain were the most frequently reported symptoms while receiving treatment in both the interviews and PRI. These symptoms had a meaningful impact on health-related quality of life (HRQOL); being off treatment and returning to normal living was described as an ideal treatment outcome. Nearly all interview participants (n = 18) preferred a treatment that would allow for a treatment-free interval, if it had the same efficacy and safety profile as a continuous treatment. Conclusion: The symptom experience reported in this study is consistent with known RRMM symptoms and HRQOL impacts. Additionally, this study highlighted that patients' treatment expectations are changing relative to their past treatment experience. Individuals living with RRMM strongly desire therapies with a treatment-free interval and minimal impact on their HRQOL.
MeSH term(s)	Adult ; Humans ; Female ; Middle Aged ; Male ; Multiple Myeloma/drug therapy ; Quality of Life ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Treatment Outcome ; Patient Outcome Assessment
Language	English
Publishing date	2022-02-15
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2573-8348
ISSN (online)	2573-8348
DOI	10.1002/cnr2.1603
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Article: Adjusted Comparison of Outcomes between Patients from CARTITUDE-1 versus Multiple Myeloma Patients with Prior Exposure to PI, Imid and Anti-CD-38 from a German Registry.

Merz, Maximilian / Goldschmidt, Hartmut / Hari, Parameswaran / Agha, Mounzer / Diels, Joris / Ghilotti, Francesca / Perualila, Nolen J / Cabrieto, Jedelyn / Haefliger, Benjamin / Sliwka, Henrik / Schecter, Jordan M / Jackson, Carolyn C / Olyslager, Yunsi / Akram, Muhammad / Nesheiwat, Tonia / Kellermann, Lenka / Jagannath, Sundar

Cancers

2021 Volume 13, Issue 23

Abstract: Ciltacabtagene autoleucel (cilta-cel) is a Chimeric antigen receptor T-cell therapy with the potential for long-term disease control in heavily pre-treated patients with relapsed/refractory multiple myeloma (RRMM). As cilta-cel was assessed in the single- ...

Abstract	Ciltacabtagene autoleucel (cilta-cel) is a Chimeric antigen receptor T-cell therapy with the potential for long-term disease control in heavily pre-treated patients with relapsed/refractory multiple myeloma (RRMM). As cilta-cel was assessed in the single-arm CARTITUDE-1 clinical trial, we used an external cohort of patients from the Therapie Monitor registry fulfilling the CARTITUDE-1 inclusion criteria to evaluate the effectiveness of cilta-cel for overall survival (OS) and time to next treatment (TTNT) vs. real-world clinical practice. Individual patient data allowed us to adjust the comparisons between both cohorts, using the inverse probability of treatment weighting (IPW; average treatment effect in the treated population (ATT) and overlap population (ATO) weights) and multivariable Cox proportional hazards regression. Outcomes were compared in intention-to-treat (HR, IPW-ATT: TTNT: 0.13 (95% CI: 0.07, 0.24); OS: 0.14 (95% CI: 0.07, 0.25); IPW-ATO: TTNT: 0.24 (95% CI: 0.12, 0.49); OS: 0.26 (95% CI: 0.13, 0.54)) and modified intention-to-treat (HR, IPW-ATT: TTNT: 0.24 (95% CI: 0.09, 0.67); OS: 0.26 (95% CI: 0.08, 0.84); IPW-ATO: TTNT: 0.26 (95% CI: 0.11, 0.59); OS: 0.31 (95% CI: 0.12, 0.79)) populations. All the comparisons were statistically significant in favor of cilta-cel. These results highlight cilta-cel's potential as a novel, effective treatment to address unmet needs in patients with RRMM.
Language	English
Publishing date	2021-11-29
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers13235996
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Article ; Online: Comparative effectiveness of ciltacabtagene autoleucel in CARTITUDE-1 versus physician's choice of therapy in the Flatiron Health multiple myeloma cohort registry for the treatment of patients with relapsed or refractory multiple myeloma.

Martin, Thomas / Krishnan, Amrita / Yong, Kwee / Weisel, Katja / Mehra, Maneesha / Nair, Sandhya / Qi, Keqin / Londhe, Anil / Diels, Joris / Crivera, Concetta / Jackson, Carolyn C / Olyslager, Yunsi / Vogel, Martin / Schecter, Jordan M / Banerjee, Arnob / Valluri, Satish / Usmani, Saad Z / Berdeja, Jesus G / Jagannath, Sundar

EJHaem

2021 Volume 3, Issue 1, Page(s) 97–108

Abstract: Introduction: Ciltacabtagene autoleucel (cilta-cel) is a novel chimeric antigen receptor T-cell therapy that is being evaluated in the CARTITUDE-1 trial (NCT03548207) in patients with relapsed or refractory multiple myeloma (RRMM) who received as part ... ...

Abstract	Introduction: Ciltacabtagene autoleucel (cilta-cel) is a novel chimeric antigen receptor T-cell therapy that is being evaluated in the CARTITUDE-1 trial (NCT03548207) in patients with relapsed or refractory multiple myeloma (RRMM) who received as part of their previous therapy an immunomodulatory drug, proteasome inhibitor, and an anti-CD38 monoclonal antibody (i.e., triple-class exposed). Given the absence of a control arm in CARTITUDE-1, this study assessed the comparative effectiveness of cilta-cel and physician's choice of treatment (PCT) using an external real-world control arm from the Flatiron Health multiple myeloma cohort registry. Methods: Given the availability of individual patient data for cilta-cel from CARTITUDE-1 and PCT in Flatiron, inverse probability of treatment weighting was used to adjust for unbalanced baseline covariates of prognostic significance: refractory status, cytogenetic profile, International Staging System stage, time to progression on last regimen, number of prior lines of therapy, years since diagnosis, and age. Comparative effectiveness was estimated for progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS). A range of sensitivity analyses were conducted. Results: Baseline characteristics were similar between the two cohorts after propensity score weighting. Patients with cilta-cel had improved PFS (HR: 0.18 [95% CI: 0.12, 0.27; Conclusion: Cilta-cel demonstrated significantly superior effectiveness over PCT for all outcomes, highlighting its potential as an effective therapy in patients with triple-class exposed RRMM.
Language	English
Publishing date	2021-12-10
Publishing country	United States
Document type	Journal Article
ISSN	2688-6146
ISSN (online)	2688-6146
DOI	10.1002/jha2.312
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Article ; Online: Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study.

Clinical lymphoma, myeloma & leukemia

2022 Volume 23, Issue 1, Page(s) 68–77

Abstract: Introduction: Ciltacabtagene autoleucel (cilta-cel), a novel chimeric antigen receptor T (CAR-T) cell therapy, has demonstrated early, deep, and durable clinical responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM), ... ...

Abstract	Introduction: Ciltacabtagene autoleucel (cilta-cel), a novel chimeric antigen receptor T (CAR-T) cell therapy, has demonstrated early, deep, and durable clinical responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM), and improvements in health-related quality of life (HRQoL) in CARTITUDE-1 (NCT03548207). Patient perspectives on treatment provide context to efficacy outcomes and are an important aspect of therapeutic evaluation. Methods: Qualitative interviews were conducted in a subset of CARTITUDE-1 patients (n = 36) at screening, Day 100, and Day 184 post cilta-cel on living with MM, therapy expectations, and treatment experiences during the study. Results: Patients most wanted to see change in symptoms with the greatest impact on HRQoL: pain (85.2%) and fatigue (74.1%). The primary treatment expectation was achieving remission (40.7%), followed by extended life expectancy (14.8%). Patients most often defined meaningful change as improvement in symptoms (70.4%) and return to normalcy (40.7%). The percentage of patients reporting symptoms (pain, fatigue, bone fracture, gastrointestinal, neuropathy, and weakness) decreased from 85.2% to 22.2% across symptom types at baseline to 29.2% to 0% on Day 184 after cilta-cel. Improved symptoms and positive sentiments corresponded with improved perception of overall health status and reduced pain level, respectively. Most patients reported that their expectations of cilta-cel treatment had been met (70.8%) or exceeded (20.8%) at Day 184, and 70.8% of patients considered cilta-cel therapy better than their previous treatments. Conclusion: Overall HRQoL improvements and qualitative interviews showed cilta-cel met patient expectations of treatment and suggest the long treatment-free period also contributed to positive sentiments.
MeSH term(s)	Humans ; Multiple Myeloma/drug therapy ; Quality of Life ; Immunotherapy, Adoptive/methods ; Fatigue ; Pain/etiology
Language	English
Publishing date	2022-10-11
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2540992-X
ISSN	2152-2669 ; 2152-2650
ISSN (online)	2152-2669
ISSN	2152-2650
DOI	10.1016/j.clml.2022.10.001
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Article ; Online: Health-related quality of life in patients given ciltacabtagene autoleucel for relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b-2, open-label study.

The Lancet. Haematology

2022 Volume 9, Issue 12, Page(s) e897–e905

Abstract: Background: CARTITUDE-1 is a phase 1b-2 study evaluating ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T cell therapy with two B-cell maturation antigen-targeting single-domain antibodies, in patients with relapsed or refractory ... ...

Abstract	Background: CARTITUDE-1 is a phase 1b-2 study evaluating ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T cell therapy with two B-cell maturation antigen-targeting single-domain antibodies, in patients with relapsed or refractory multiple myeloma. Primary efficacy outcomes have previously been reported. Here, we report health-related quality of life (HRQOL) secondary outcomes evaluated using patient-reported outcomes. Methods: This single-arm, open-label, phwase 1b-2 study was done at 16 centres in the USA. Patients were aged 18 years or older with diagnosis of multiple myeloma and Eastern Cooperative Oncology Group performance status of 1 or less with three or more previous lines of therapy, or were double refractory to a proteasome inhibitor and immunomodulatory drug, and had received a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody. A single cilta-cel infusion (target dose 0·75 × 10 Findings: Between July 16, 2018, and Oct 7, 2019, 78 patients were enrolled and underwent apheresis in phase 2 of the study. 68 patients were treated (43 [63%] male, 49 [72%] White), and their patient-reported outcomes assessed (median follow-up 16·9 months, IQR 15·7-17·5). After infusion, a transient decline was observed, followed by improvements in global health status (mean change from baseline to day 464 +8·0 points, SD 20·9), physical (+4·6 points, 21·1), and emotional functional scales (+1·9 points, 23·7) over time, and declines for symptom-based scores (-14·1 pain, SD 31·5 and -15·4 fatigue; SD 29·5), indicating improved patient HRQOL following treatment with cilta-cel. Interpretation: These durable HRQOL improvements are consistent with clinical findings, in which a single cilta-cel infusion led to substantial and durable responses in heavily pre-treated patients with relapsed or refractory multiple myeloma. These results support the use of cilta-cel in patients with relapsed or refractory multiple myeloma. Funding: Janssen Research & Development and Legend Biotech USA.
MeSH term(s)	Humans ; Male ; Female ; Multiple Myeloma/drug therapy ; Quality of Life ; Proteasome Inhibitors/therapeutic use ; Follow-Up Studies ; B-Cell Maturation Antigen ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use
Chemical Substances	Proteasome Inhibitors ; B-Cell Maturation Antigen
Language	English
Publishing date	2022-10-07
Publishing country	England
Document type	Clinical Trial, Phase I ; Journal Article
ISSN	2352-3026
ISSN (online)	2352-3026
DOI	10.1016/S2352-3026(22)00284-8
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Article ; Online: Incidence and management of CAR-T neurotoxicity in patients with multiple myeloma treated with ciltacabtagene autoleucel in CARTITUDE studies.

Cohen, Adam D / Parekh, Samir / Santomasso, Bianca D / Gállego Pérez-Larraya, Jaime / van de Donk, Niels W C J / Arnulf, Bertrand / Mateos, Maria-Victoria / Lendvai, Nikoletta / Jackson, Carolyn C / De Braganca, Kevin C / Schecter, Jordan M / Marquez, Loreta / Lee, Erin / Cornax, Ingrid / Zudaire, Enrique / Li, Claire / Olyslager, Yunsi / Madduri, Deepu / Varsos, Helen /

Pacaud, Lida / Akram, Muhammad / Geng, Dong / Jakubowiak, Andrzej / Einsele, Hermann / Jagannath, Sundar

Blood cancer journal

2022 Volume 12, Issue 2, Page(s) 32

Abstract: Chimeric antigen receptor (CAR) T-cell therapies are highly effective for multiple myeloma (MM) but their impressive efficacy is associated with treatment-related neurotoxicities in some patients. In CARTITUDE-1, 5% of patients with MM reported movement ... ...

Abstract	Chimeric antigen receptor (CAR) T-cell therapies are highly effective for multiple myeloma (MM) but their impressive efficacy is associated with treatment-related neurotoxicities in some patients. In CARTITUDE-1, 5% of patients with MM reported movement and neurocognitive treatment-emergent adverse events (MNTs) with ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen-targeted CAR T-cell therapy. We assessed the associated factors for MNTs in CARTITUDE-1. Based on common features, patients who experienced MNTs were characterized by the presence of a combination of at least two variables: high tumor burden, grade ≥2 cytokine release syndrome (CRS) or any grade immune effector cell-associated neurotoxicity syndrome (ICANS) after cilta-cel infusion, and high CAR T-cell expansion/persistence. Strategies were implemented across the cilta-cel development program to monitor and manage patients with MNTs, including enhanced bridging therapy to reduce baseline tumor burden, early aggressive treatment of CRS and ICANS, handwriting assessments for early symptom detection, and extended monitoring/reporting time for neurotoxicity beyond 100 days post-infusion. After successful implementation of these strategies, the incidence of MNTs was reduced from 5% to <1% across the cilta-cel program, supporting its favorable benefit-risk profile for treatment of MM.
MeSH term(s)	Humans ; Immunotherapy, Adoptive/adverse effects ; Incidence ; Multiple Myeloma/complications ; Multiple Myeloma/therapy ; Neurotoxicity Syndromes/etiology ; Receptors, Chimeric Antigen/therapeutic use
Chemical Substances	Receptors, Chimeric Antigen
Language	English
Publishing date	2022-02-24
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2600560-8
ISSN	2044-5385 ; 2044-5385
ISSN (online)	2044-5385
ISSN	2044-5385
DOI	10.1038/s41408-022-00629-1
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Article ; Online: Teclistamab in Relapsed or Refractory Multiple Myeloma.

Moreau, Philippe / Garfall, Alfred L / van de Donk, Niels W C J / Nahi, Hareth / San-Miguel, Jesús F / Oriol, Albert / Nooka, Ajay K / Martin, Thomas / Rosinol, Laura / Chari, Ajai / Karlin, Lionel / Benboubker, Lotfi / Mateos, Maria-Victoria / Bahlis, Nizar / Popat, Rakesh / Besemer, Britta / Martínez-López, Joaquín / Sidana, Surbhi / Delforge, Michel /

Pei, Lixia / Trancucci, Danielle / Verona, Raluca / Girgis, Suzette / Lin, Shun X W / Olyslager, Yunsi / Jaffe, Mindy / Uhlar, Clarissa / Stephenson, Tara / Van Rampelbergh, Rian / Banerjee, Arnob / Goldberg, Jenna D / Kobos, Rachel / Krishnan, Amrita / Usmani, Saad Z

The New England journal of medicine

2022 Volume 387, Issue 6, Page(s) 495–505

Abstract: Background: Teclistamab is a T-cell-redirecting bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen expressed on the surface of myeloma cells. In the phase 1 dose-defining portion of the study, ... ...

Abstract	Background: Teclistamab is a T-cell-redirecting bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen expressed on the surface of myeloma cells. In the phase 1 dose-defining portion of the study, teclistamab showed promising efficacy in patients with relapsed or refractory multiple myeloma. Methods: In this phase 1-2 study, we enrolled patients who had relapsed or refractory myeloma after at least three therapy lines, including triple-class exposure to an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. Patients received a weekly subcutaneous injection of teclistamab (at a dose of 1.5 mg per kilogram of body weight) after receiving step-up doses of 0.06 mg and 0.3 mg per kilogram. The primary end point was the overall response (partial response or better). Results: Among 165 patients who received teclistamab, 77.6% had triple-class refractory disease (median, five previous therapy lines). With a median follow-up of 14.1 months, the overall response rate was 63.0%, with 65 patients (39.4%) having a complete response or better. A total of 44 patients (26.7%) were found to have no minimal residual disease (MRD); the MRD-negativity rate among the patients with a complete response or better was 46%. The median duration of response was 18.4 months (95% confidence interval [CI], 14.9 to not estimable). The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1). Common adverse events included cytokine release syndrome (in 72.1% of the patients; grade 3, 0.6%; no grade 4), neutropenia (in 70.9%; grade 3 or 4, 64.2%), anemia (in 52.1%; grade 3 or 4, 37.0%), and thrombocytopenia (in 40.0%; grade 3 or 4, 21.2%). Infections were frequent (in 76.4%; grade 3 or 4, 44.8%). Neurotoxic events occurred in 24 patients (14.5%), including immune effector cell-associated neurotoxicity syndrome in 5 patients (3.0%; all grade 1 or 2). Conclusions: Teclistamab resulted in a high rate of deep and durable response in patients with triple-class-exposed relapsed or refractory multiple myeloma. Cytopenias and infections were common; toxic effects that were consistent with T-cell redirection were mostly grade 1 or 2. (Funded by Janssen Research and Development; MajesTEC-1 ClinicalTrials.gov numbers, NCT03145181 and NCT04557098.).
MeSH term(s)	Antibodies, Bispecific/administration & dosage ; Antibodies, Bispecific/adverse effects ; Antibodies, Bispecific/therapeutic use ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/adverse effects ; Antineoplastic Agents, Immunological/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; B-Cell Maturation Antigen/antagonists & inhibitors ; CD3 Complex/antagonists & inhibitors ; Humans ; Injections, Subcutaneous ; Multiple Myeloma/drug therapy ; Multiple Myeloma/immunology ; Multiple Myeloma/pathology ; Neoplasm Recurrence, Local/drug therapy ; Recurrence ; T-Lymphocytes/drug effects ; T-Lymphocytes/immunology
Chemical Substances	Antibodies, Bispecific ; Antibodies, Monoclonal, Humanized ; Antineoplastic Agents ; Antineoplastic Agents, Immunological ; B-Cell Maturation Antigen ; CD3 Complex ; TNFRSF17 protein, human
Language	English
Publishing date	2022-06-05
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2203478
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Article ; Online: Ciltacabtagene Autoleucel, an Anti-B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up.

Martin, Thomas / Usmani, Saad Z / Berdeja, Jesus G / Agha, Mounzer / Cohen, Adam D / Hari, Parameswaran / Avigan, David / Deol, Abhinav / Htut, Myo / Lesokhin, Alexander / Munshi, Nikhil C / O'Donnell, Elizabeth / Stewart, A Keith / Schecter, Jordan M / Goldberg, Jenna D / Jackson, Carolyn C / Yeh, Tzu-Min / Banerjee, Arnob / Allred, Alicia /

Zudaire, Enrique / Deraedt, William / Olyslager, Yunsi / Zhou, Changwei / Pacaud, Lida / Madduri, Deepu / Jakubowiak, Andrzej / Lin, Yi / Jagannath, Sundar

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2022 Volume 41, Issue 6, Page(s) 1265–1274

Abstract: Purpose: CARTITUDE-1, a phase Ib/II study evaluating the safety and efficacy of ciltacabtagene autoleucel (cilta-cel) in heavily pretreated patients with relapsed/refractory multiple myeloma, yielded early, deep, and durable responses at 12 months. Here, ...

Abstract	Purpose: CARTITUDE-1, a phase Ib/II study evaluating the safety and efficacy of ciltacabtagene autoleucel (cilta-cel) in heavily pretreated patients with relapsed/refractory multiple myeloma, yielded early, deep, and durable responses at 12 months. Here, we present updated results 2 years after last patient in (median follow-up [MFU] approximately 28 months), including analyses of high-risk patient subgroups. Methods: Eligible patients had relapsed/refractory multiple myeloma, had received ≥ 3 prior lines of therapy or were double refractory to a proteasome inhibitor and immunomodulatory drug and had received prior proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy. Patients received a single cilta-cel infusion 5-7 days after lymphodepletion. Responses were assessed by an independent review committee. Results: At a MFU of 27.7 months (N = 97), the overall response rate was 97.9% (95% CI, 92.7 to 99.7); 82.5% (95% CI, 73.4 to 89.4) of patients achieved a stringent complete response. Median duration of response was not estimable. Median progression-free survival (PFS) and overall survival (OS) were not reached; 27-month PFS and OS rates were 54.9% (95% CI, 44.0 to 64.6) and 70.4% (95% CI, 60.1 to 78.6), respectively. Overall response rates were high across all subgroups (95.1%-100%). Duration of response, PFS, and/or OS were shorter in patients with high-risk cytogenetics, International Staging System stage III, high tumor burden, or plasmacytomas. The safety profile was manageable with no new cilta-cel-related cytokine release syndrome and one new case of parkinsonism (day 914 after cilta-cel) since the last report. Conclusion: At approximately 28 months MFU, patients treated with cilta-cel maintained deep and durable responses, observed in both standard and high-risk subgroups. The risk/benefit profile of cilta-cel remained favorable with longer follow-up.
MeSH term(s)	Humans ; B-Cell Maturation Antigen ; Cell- and Tissue-Based Therapy ; Follow-Up Studies ; Immunotherapy, Adoptive ; Multiple Myeloma/drug therapy ; Proteasome Inhibitors/therapeutic use ; Receptors, Chimeric Antigen/therapeutic use
Chemical Substances	B-Cell Maturation Antigen ; Proteasome Inhibitors ; Receptors, Chimeric Antigen
Language	English
Publishing date	2022-06-04
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.22.00842
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Article ; Online: Meta-analysis of ciltacabtagene autoleucel versus physician's choice therapy for the treatment of patients with relapsed or refractory multiple myeloma.

Costa, Luciano J / Hari, Parameswaran / Berdeja, Jesus G / De Stefano, Valerio / Gay, Francesca / Hooper, Becky / Bartlett, Meaghan / Haltner, Anja / Rosta, Emily / Kumar, Shaji / Martin, Thomas / Mateos, Maria-Victoria / Moreau, Philippe / Usmani, Saad Z / Olyslager, Yunsi / Schecter, Jordan M / Roccia, Tito / Garrett, Ashraf / Lee, Sam /

Nesheiwat, Tonia / Pacaud, Lida / Zhou, Changwei / Samjoo, Imtiaz A / Lin, Yi / Diels, Joris / Valluri, Satish / Weisel, Katja

Current medical research and opinion

2022 Volume 38, Issue 10, Page(s) 1759–1767

Abstract: Objective: ...

Abstract	Objective:
MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Humans ; Multiple Myeloma/drug therapy ; Physicians
Language	English
Publishing date	2022-08-10
Publishing country	England
Document type	Journal Article ; Meta-Analysis
ZDB-ID	80296-7
ISSN	1473-4877 ; 0300-7995
ISSN (online)	1473-4877
ISSN	0300-7995
DOI	10.1080/03007995.2022.2100651
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Article ; Online: Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study.

Berdeja, Jesus G / Madduri, Deepu / Usmani, Saad Z / Jakubowiak, Andrzej / Agha, Mounzer / Cohen, Adam D / Stewart, A Keith / Hari, Parameswaran / Htut, Myo / Lesokhin, Alexander / Deol, Abhinav / Munshi, Nikhil C / O'Donnell, Elizabeth / Avigan, David / Singh, Indrajeet / Zudaire, Enrique / Yeh, Tzu-Min / Allred, Alicia J / Olyslager, Yunsi /

Banerjee, Arnob / Jackson, Carolyn C / Goldberg, Jenna D / Schecter, Jordan M / Deraedt, William / Zhuang, Sen Hong / Infante, Jeffrey / Geng, Dong / Wu, Xiaoling / Carrasco-Alfonso, Marlene J / Akram, Muhammad / Hossain, Farah / Rizvi, Syed / Fan, Frank / Lin, Yi / Martin, Thomas / Jagannath, Sundar

Lancet (London, England)

2021 Volume 398, Issue 10297, Page(s) 314–324

Abstract: Background: CARTITUDE-1 aimed to assess the safety and clinical activity of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T-cell therapy with two B-cell maturation antigen-targeting single-domain antibodies, in patients with ... ...

Abstract	Background: CARTITUDE-1 aimed to assess the safety and clinical activity of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T-cell therapy with two B-cell maturation antigen-targeting single-domain antibodies, in patients with relapsed or refractory multiple myeloma with poor prognosis. Methods: This single-arm, open-label, phase 1b/2 study done at 16 centres in the USA enrolled patients aged 18 years or older with a diagnosis of multiple myeloma and an Eastern Cooperative Oncology Group performance status score of 0 or 1, who received 3 or more previous lines of therapy or were double-refractory to a proteasome inhibitor and an immunomodulatory drug, and had received a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody. A single cilta-cel infusion (target dose 0·75 × 10 Findings: Between July 16, 2018, and Oct 7, 2019, 113 patients were enrolled. 97 patients (29 in phase 1b and 68 in phase 2) received a cilta-cel infusion at the recommended phase 2 dose of 0·75 × 10 Interpretation: A single cilta-cel infusion at the target dose of 0·75 × 10 Funding: Janssen Research & Development and Legend Biotech.
MeSH term(s)	Aged ; B-Cell Maturation Antigen/administration & dosage ; Female ; Humans ; Immunotherapy, Adoptive/methods ; Male ; Middle Aged ; Multiple Myeloma/drug therapy ; Progression-Free Survival ; Receptors, Chimeric Antigen/administration & dosage ; United States
Chemical Substances	B-Cell Maturation Antigen ; Receptors, Chimeric Antigen
Language	English
Publishing date	2021-06-24
Publishing country	England
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(21)00933-8
Database	MEDical Literature Analysis and Retrieval System OnLINE

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